2020
Principles of Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND)
Schuemie MJ, Ryan PB, Pratt N, Chen R, You SC, Krumholz HM, Madigan D, Hripcsak G, Suchard MA. Principles of Large-scale Evidence Generation and Evaluation across a Network of Databases (LEGEND). Journal Of The American Medical Informatics Association 2020, 27: 1331-1337. PMID: 32909033, PMCID: PMC7481029, DOI: 10.1093/jamia/ocaa103.Peer-Reviewed Original ResearchConceptsNetwork of databasesLarge-scale Evidence GenerationObservational Health Data SciencesObservational health care databasesHealth Data SciencesHealth care dataElectronic health recordsData sciencePublication biasPatient-level informationGeneric overviewHealth recordsMethods addressAforementioned concernsHealth care databasesAnalytic codeNetworkNew paradigmSuch dataHackingEvidence generationDissemination of evidenceHypertension treatmentResidual confoundingAdministrative claims
2018
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators
Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li S, Marinac‐Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiology And Drug Safety 2018, 27: 848-856. PMID: 29896873, PMCID: PMC6436550, DOI: 10.1002/pds.4565.Peer-Reviewed Original ResearchConceptsAdverse event ratesSafety differencesEvent ratesMedical device utilizationICD utilizationRate ratioNational Cardiovascular Data RegistryICD modelsImplantable cardioverter defibrillatorEvent rate ratioMost patientsCardioverter defibrillatorProportion of individualsAmerican CollegeData registryRoutine surveillanceSample size estimatesAverage event rateDevice utilizationSignificance levelDifferencesPatientsRegistryDefibrillatorICD
2017
Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project
Low J, Ross JS, Ritchie JD, Gross CP, Lehman R, Lin H, Fu R, Stewart LA, Krumholz HM. Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project. Systematic Reviews 2017, 6: 28. PMID: 28196521, PMCID: PMC5310069, DOI: 10.1186/s13643-017-0422-x.Peer-Reviewed Original ResearchConceptsParticipant-level dataSystematic reviewSummary estimatesRecombinant human bone morphogenetic protein-2Inclusion criteriaCenter BIndividual participant-level dataMeta-analysis inclusion criteriaHuman bone morphogenetic protein-2Trial inclusion criteriaMulti-site clinical trialMain outcome measuresMost clinical outcomesStatistical methodsConcurrent systematic reviewIndependent systematic reviewsProtein 2Bone morphogenetic protein-2Summary efficacyMorphogenetic protein-2Adverse eventsClinical outcomesSurgical approachTrial inclusionClinical trials
2014
Open Access to Clinical Trials Data
Krumholz HM, Peterson ED. Open Access to Clinical Trials Data. JAMA 2014, 312: 1002-1003. PMID: 25203080, DOI: 10.1001/jama.2014.9647.Peer-Reviewed Original ResearchReport of the independent panel considering the retraction of two articles in The BMJ
Heath I, Evans S, Furberg C, Hippisley-Cox J, Krumholz H, Mulrow C, Wicks P. Report of the independent panel considering the retraction of two articles in The BMJ. The BMJ 2014, 349: g5176. PMID: 25128486, DOI: 10.1136/bmj.g5176.Peer-Reviewed Original ResearchData Interpretation, StatisticalEditorial PoliciesHumansHydroxymethylglutaryl-CoA Reductase InhibitorsPeriodicals as TopicRetraction of Publication as TopicRiskBig Data And New Knowledge In Medicine: The Thinking, Training, And Tools Needed For A Learning Health System
Krumholz HM. Big Data And New Knowledge In Medicine: The Thinking, Training, And Tools Needed For A Learning Health System. Health Affairs 2014, 33: 1163-1170. PMID: 25006142, PMCID: PMC5459394, DOI: 10.1377/hlthaff.2014.0053.Peer-Reviewed Original ResearchMeSH KeywordsData Interpretation, StatisticalData MiningDatasets as TopicDecision Support Systems, ClinicalDelivery of Health CareHumansLearningMedical InformaticsThinkingConceptsBig dataNext-generation analyticsHealth care dataNew data sourcesAdvanced analyticsData meaningLearning health systemInformation needsUnmet information needsMassive quantitiesData sourcesHealth policy makersComplexity of patientsAnalyticsLearning health care systemComparative effectiveness researchHealth care systemPopulation health researchKnowledge generationCare dataHealth systemPatientsCare systemEffectiveness researchHealth research
2013
The China Patient-Centered Evaluative Assessment of Cardiac Events (China PEACE) Retrospective Study of Acute Myocardial Infarction
Dharmarajan K, Li J, Li X, Lin Z, Krumholz HM, Jiang L. The China Patient-Centered Evaluative Assessment of Cardiac Events (China PEACE) Retrospective Study of Acute Myocardial Infarction. Circulation Cardiovascular Quality And Outcomes 2013, 6: 732-740. PMID: 24221838, PMCID: PMC4054693, DOI: 10.1161/circoutcomes.113.000441.Peer-Reviewed Original ResearchMeSH KeywordsChinaData Interpretation, StatisticalEpidemiologic Research DesignHospitalsHumansKnowledge BasesMyocardial InfarctionQuality ImprovementRetrospective StudiesConceptsChina PEACE-Retrospective AMI StudyAcute myocardial infarctionChina PatientRetrospective studyMyocardial infarctionOutcomes of patientsAMI studyDiagnostic testing patternsCause of deathSite of careCardiac eventsHospital outcomesPatient characteristicsHospital treatmentCardiovascular diseaseCase ascertainmentImproved care
2012
Documenting the Methods History
Krumholz HM. Documenting the Methods History. Circulation Cardiovascular Quality And Outcomes 2012, 5: 418-419. PMID: 22811497, DOI: 10.1161/circoutcomes.112.967646.Peer-Reviewed Original ResearchBiomedical ResearchData Interpretation, StatisticalEditorial PoliciesHumansPeriodicals as TopicReproducibility of ResultsResearch Design
2011
A Model for Dissemination and Independent Analysis of Industry Data
Krumholz HM, Ross JS. A Model for Dissemination and Independent Analysis of Industry Data. JAMA 2011, 306: 1593-1594. PMID: 21990302, PMCID: PMC3688082, DOI: 10.1001/jama.2011.1459.Commentaries, Editorials and Letters
2005
The generalizability of observational data to elderly patients was dependent on the research question in a systematic review
Gross CP, Garg PP, Krumholz HM. The generalizability of observational data to elderly patients was dependent on the research question in a systematic review. Journal Of Clinical Epidemiology 2005, 58: 130-137. PMID: 15680745, DOI: 10.1016/j.jclinepi.2004.10.001.Peer-Reviewed Original ResearchConceptsCooperative Cardiovascular ProjectIntracranial hemorrhageSystematic reviewBeta-blocker useElderly patientsAngiography useCommunity patientsAtrial fibrillationRisk factorsObservational studyOutcome measuresRCT dataPresentation delayGlobal UtilizationT-PAPatientsSimilar predictorsTreatment variationStudy questionsCCP dataGUSTOHemorrhageReviewFibrillationAbsolute rate
2003
Association of Serum Digoxin Concentration and Outcomes in Patients With Heart Failure
Rathore SS, Curtis JP, Wang Y, Bristow MR, Krumholz HM. Association of Serum Digoxin Concentration and Outcomes in Patients With Heart Failure. JAMA 2003, 289: 871-878. PMID: 12588271, DOI: 10.1001/jama.289.7.871.Peer-Reviewed Original ResearchMeSH KeywordsCardiotonic AgentsData Interpretation, StatisticalDigoxinFemaleHeart FailureHospitalizationHumansMaleMiddle AgedSurvival AnalysisTreatment OutcomeVentricular Dysfunction, LeftConceptsSerum digoxin concentrationHigh serum digoxin concentrationsLeft ventricular ejection fractionVentricular ejection fractionHeart failureMortality rateDIG trialDigoxin therapyEjection fractionDigoxin concentrationsDepressed left ventricular systolic functionDigitalis Investigation Group trialHigher absolute mortality rateLeft ventricular systolic functionOverall mortality benefitVentricular systolic functionCause mortality ratesAbsolute mortality ratesLower mortality rateCause mortalityMultivariable adjustmentMortality benefitSystolic functionClinical outcomesSerum concentrations
2002
Reporting the recruitment process in clinical trials: who are these patients and how did they get there?
Gross CP, Mallory R, Heiat A, Krumholz HM. Reporting the recruitment process in clinical trials: who are these patients and how did they get there? Annals Of Internal Medicine 2002, 137: 10-6. PMID: 12093240, DOI: 10.7326/0003-4819-137-1-200207020-00007.Peer-Reviewed Original ResearchMeSH KeywordsCross-Sectional StudiesData Interpretation, StatisticalPatient SelectionRandomized Controlled Trials as TopicConceptsNumber of personsMedian proportionPotential study participantsMedical journalsClinical trialsEligible personsHigh-impact medical journalsGeneral populationRCTsMajor medical journalsStudy participantsPatient recruitment processStudy sampleTrialsEligibilityPersonsExplicit reviewProportionEnrollment processParticipantsPatients
2000
Quality improvement studies: the need is there but so are the challenges
Krumholz H, Herrin J. Quality improvement studies: the need is there but so are the challenges. The American Journal Of Medicine 2000, 109: 501-503. PMID: 11042244, DOI: 10.1016/s0002-9343(00)00593-3.Peer-Reviewed Original Research